Promoting Adherence to a Regimen of risk factor modification by Trained Non-medical personnel Evaluated against Regular practice Study

Promoting adherence to a regimen of risk factor modification by trained non-medical personnel evaluated against regular practice: a open-label randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07607027

Enrollment

316

Registered

2009-03-09

Start date

2009-04-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke/transient ischaemic attack (TIA) Circulatory System Other cerebrovascular diseases

Interventions

This is an open-label randomised controlled trial with equal number of subjects in both arms: 1. Regular practice (RP) 2. Regular practice plus volunteer-facilitated risk factor modification program

subjects in this group will receive standard medical care. Subjects in the RV group will receive standard medical care and scheduled contact with a trained volunteer. The volunteers will serve as heal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects aged 18 years or greater, either sex, who: 1. Experienced transient ischaemic attack or non-disabling stroke within 90 days of randomisation 2. Have hypertension

Exclusion criteria

Exclusion criteria: 1. Neuroimaging studies suggest other causes for presenting event (e.g., primary intracerebral haemorrhage, tumour, etc.) 2. Unable to communicate in English or French, or severe aphasia 3. Moderate to severe disability with modified Rankin Scale score greater than or equal to 3 4. Known dementia 5. Severe concomitant medical conditions with life expectancy of less than two years 6. Unable or unwilling to return for study-related scheduled follow-ups 7. Concurrent participation in other interventional studies

Design outcomes

Primary

Measure	Time frame
Difference between the 12-month and the baseline systolic blood pressure (SBP).	—

Secondary

Measure	Time frame
Efficacy outcome measures: The difference between the 12-month and baseline values of the following: 1. Diastolic blood pressure (DBP) 2. Medication adherence rate 3. Body mass index 4. Cardiovascular risk score 5. Waist circumference 6. Low density lipoprotein cholesterol (LDL-C) concentration 7. Total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio 8. HbA1c level 9. Cigarette smoking status 10. Alcohol consumption rate 11. Level of physical activities 12. Quality of life (SF-36) 13. Cognitive tests scores The differences between the 24-month and baseline values of these same factors, plus the difference between the 24-month and baseline SBP, constitute the durability outcome measures Other outcome measures: 14. Clinical outcome event (stroke, myocardial infarction [MI], all-cause death) 15. Estimated total healthcare expenditure	—

Measure

Time frame

Efficacy outcome measures: The difference between the 12-month and baseline values of the following: 1. Diastolic blood pressure (DBP) 2. Medication adherence rate 3. Body mass index 4. Cardiovascular risk score 5. Waist circumference 6. Low density lipoprotein cholesterol (LDL-C) concentration 7. Total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio 8. HbA1c level 9. Cigarette smoking status 10. Alcohol consumption rate 11. Level of physical activities 12. Quality of life (SF-36) 13. Cognitive tests scores The differences between the 24-month and baseline values of these same factors, plus the difference between the 24-month and baseline SBP, constitute the durability outcome measures Other outcome measures: 14. Clinical outcome event (stroke, myocardial infarction [MI], all-cause death) 15. Estimated total healthcare expenditure

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Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026